600 mg / 200 mg / 245 mg film-coated tablets 
efavirenz / emtricitabine / tenofovir disoproxil (efavirenzum / emtricitabinum / tenofovirum disoproxilum)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is and what it is used for 
2. What you need to know before you use Efavirenz / Emtricitabine / Tenofovir disoproxil Krka 
3. How to use Efavirenz / Emtricitabine / Tenofovir disoproxil Krka 
4. Possible side effects 
5. How to store Efavirenz / Emtricitabine / Tenofovir disoproxil Krka 
6. Contents of the pack and other information 

What Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is and what it is used for

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka contains three active substances used to treat human immunodeficiency virus ( HIV ) infection :

  • Efavirenz is a nucleoside non-reverse transcriptase inhibitor (NNRTI)
  • Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
  • Tenofovir is a nucleotide-type reverse transcriptase inhibitor (NRTI)

These three active substances are antiretroviral drugs that act by affecting the normal function of an enzyme (reverse transcriptase) that the virus needs for its reproduction.

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is a treatment for human immunodeficiency virus ( HIV ) infection in adults aged 18 years and older who have previously been treated with other antiretroviral drugs and who have their HIV‑1 infection under control for at least three months. Patients must not have shown treatment failure with previous HIV treatment.

What you need to know before you use Efavirenz / Emtricitabine / Tenofovir disoproxil Krka

Do not use Efavirenz / Emtricitabine / Tenofovir disoproxil Krka

  • If you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
  • If you have severe liver disease
  • If you have heart problems, such as an arrhythmia called QT prolongation. This can lead to a high risk of developing severe heart rhythm problems ( torsade de pointes ).
  • If someone in your family (parents, grandparents, brothers, or sisters) has died suddenly due to heart problems or was born with heart problems.
  • If your doctor has told you that you have high or low levels of electrolytes, such as potassium or magnesium, in your blood.
  • If you are taking any of the following medicines at the same time (see also “Other medicines and Efavirenz / Emtricitabine / Tenofovir disoproxil Krka”):
    • astemizole or terfenadine (used to treat hay fever or other allergies )
    • bepridil (used to treat heart disease)
    • cisapride (used to treat heartburn)
    • elbasvir/grazoprevir (used to treat hepatitis C)
    • ergot alkaloids (eg ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
    • midazolam or triazolam (sleeping pills)
    • pimozide, imipramine, amitriptyline, or clomipramine  (used to treat certain mental conditions)
    • St. John’s wort ( Hypericum perforatum ) (an herbal medicine used to treat depression and anxiety)
    • voriconazole (used to treat fungal infections)
    • flecainide, metoprolol (for the treatment of irregular heartbeat)
    • certain antibiotics ( macrolides , fluoroquinolones , imidazole)
    • certain antifungal drugs (triazoles)
    • certain anti-malarial drugs
    • methadone (for the treatment of opioid dependence).

→ If you are taking any of these medicines, tell your doctor immediately. Taking these medicines together with Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may cause serious or life-threatening side effects or counteract the effects of these medicines.

Warnings and cautions

Talk to your doctor or pharmacist before taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka.

  • You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others. This medicine does not cure HIV – infection. While taking efavirenz/emtricitabine/tenofovir disoproxil Krka may still develop infections you or other illnesses associated with HIV – infection.
  • You must continue to be under medical supervision while taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka.
  • Inform your doctor:
    • if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine or adefovir dipivoxil. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka should not be taken with any of these medicines.
    • if you have or have had kidney disease or if tests have shown that you have kidney problems. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is not recommended if you have moderate to severe kidney disease.
      Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may affect your kidneys. Before starting treatment, your doctor may prescribe a blood test to check your kidney function. Your doctor may also prescribe blood tests during treatment to check your kidneys.
      Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is not usually taken with other medicines that can damage the kidneys (see Other medicines and Efavirenz / Emtricitabine / Tenofovir disoproxil Krka ). If this is unavoidable, your doctor will check your kidney function once a week.
    • if you have a heart condition, such as an abnormal electrical signal called an extended QT interval.
    • if you have had a mental illness including depression or drug or alcohol abuse. Talk immediately to your doctor if you feel depressed, have suicidal thoughts, or have strange thoughts (see section 4, Possible side effect s ).
    • if you have had seizures or if you are being treated with anticonvulsants such as carbamazepine, phenobarbital, and phenytoin. If you are taking any of these medicines, your doctor may need to check how much of the medicine is in your blood to ensure that it is not affected when you take Efavirenz / Emtricitabine / Tenofovir disoproxil Krka. Your doctor may give you another medicine for seizures.
    • if you have had liver disease, including chronic active hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are being treated with combination antivirals are at increased risk of serious and potentially life-threatening liver problems. Your doctor may take blood samples to check your liver function or allow you to switch to another medicine. If you have severe liver disease, do not take Efavirenz / Emtricitabine / Tenofovir disoproxil Krka (see earlier in section 2, Do not take Efavirenz / Emtricitabine / Tenofovir disoproxil Krka ).
      If you have a hepatitis B infection, your doctor will carefully choose the best treatment for you. Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, have some activity against hepatitis B virus even though emtricitabine is not approved for the treatment of hepatitis B infection. The symptoms of your hepatitis may worsen after you stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka. Your doctor may then take blood tests regularly to check your liver function (see section 3, If you stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka ).
      Whether or not you have had liver disease, your doctor will consider taking regular blood tests to check your liver function.
    • if you are over 65 years old. An insufficient number of patients over the age of 65 have been studied. If you are over 65 years of age and have been prescribed Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, your doctor will monitor you closely.
  • When you start taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka you should be observant of:
    • symptoms such as dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects can occur in the first 1 to 2 days after treatment and usually disappear after 2 to 4 weeks.
    • symptoms of the rash. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may cause rash. If you notice symptoms of severe rash with blistering or fever, stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka and tell your doctor straight away. If you get a rash while taking another NNRTI, you may be at greater risk of getting a rash with Efavirenz / Emtricitabine / Tenofovir disoproxil Krka.
    • symptoms of inflammation or infection. In some patients with advanced HIV – infection ( AIDS ) and a history of opportunistic infection, you may be signs and symptoms of inflammation from previous infections that may occur soon after anti- HIV started. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present but without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection.
      In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.
    • skeletal problems. Some patients receiving combination antiretroviral therapy may develop a skeletal disease called osteonecrosis (skeletal tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
      Skeletal problems (which sometimes lead to fractures ) can also occur due to damage to the renal tubules (see section 4, Possible side effects ).

Children and young people

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka should not be used in children and adolescents below 18 years of age. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka has not yet been studied in children and adolescents.

Other medicines and Efavirenz / Emtricitabine / Tenofovir disoproxil Krka

You must not take certain medicines with you

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka. These are listed under Do not take Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, at the beginning of section 2 and include certain common medicines and certain herbal medicines (including St. John’s wort ) which may cause serious interactions 

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Besides, Efavirenz / Emtricitabine / Tenofovir disoproxil Krka should not be taken with other medicines containing efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine, or adefovir dipivoxil.

Tell your doctor if you are taking other medicines that may damage your kidneys. Examples of such drugs are:

  • aminoglycosides, vancomycin (medicine for bacterial infection )
  • foskarnet, ganciclovir, cidofovir (medicines for viral infections)
  • amphotericin B, pentamidine (medicine for fungal infections)
  • interleukin ‑2 (for the treatment of cancer)
  • non-steroidal anti-inflammatory drugs ( NSAIDs, to relieve skeletal or muscle pain)

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may interact with other medicines, including herbal medicines such as Ginkgo biloba extract. As a result, the amount of Efavirenz / Emtricitabine / Tenofovir disoproxil Krka or other medicines in the blood may be affected. This can lead to the medicines not working properly or the side effects getting worse. In some cases, your doctor may need to adjust your dose or check your blood levels. You must tell your doctor or pharmacist if you are taking any of the following:

  • Medicines containing didanosine (for HIV – infection ): If you are taking efavirenz/emtricitabine/tenofovir disoproxil Krka with other antiviral medicines that contain didanosine, blood levels of didanosine and increase CD4 cell counts. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases with a fatal outcome, have been reported during concomitant treatment with drugs containing tenofovir disoproxil and didanosine. Your doctor will carefully consider whether you can be treated with medicines containing tenofovir and didanosine.
  • Other medicines used to treat HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir with an increased dose of atazanavir or saquinavir. Your doctor may consider giving you alternative medicines or changing the dose of one of your protease inhibitors. Also, tell your doctor if you are taking maraviroc.
  • Medicines used for the treatment of infection with the hepatitis C virus:elbasvir / grazoprevir, glekaprevir / pibrentasvir, sofosbuvir / velpatasvir, sofosbuvir / velpatasvir / voxilaprevir.
  • Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may reduce the number of statins in your blood. Your doctor will check your cholesterol level and, if necessary, consider changing your statin dose.
  • Medicines used to treat seizures ( antiepileptic drugs ): Carbamazepine, phenytoin, phenobarbital. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may reduce the amount of antiepileptic in your blood. Carbamazepine may reduce the amount of efavirenz, one of the ingredients in Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, in the blood. Your doctor may consider giving you another antiepileptic drug.
  • Drugs for the treatment of bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complexes: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing your dose or giving you another antibiotic. Your doctor may also consider adding a dose of efavirenz to treat your HIV – infection.
  • Medicines used to treat fungal infections: Itraconazole or posaconazole. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may reduce the amount of itraconazole or posaconazole in the blood. Your doctor may consider giving you another medicine for a fungal infection.
  • Medicines used to treat malaria: Atovaquone / proguanil or artemeter / lumefantrine: Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may reduce the amount of atovaquone / proguanil or artemeter / lumefantrine in the blood.
  • Hormonal contraceptives, such as birth control pills, an injected contraceptive (eg Depo-Provera), or a contraceptive implant (eg Implanon): You must always use a reliable barrier contraceptive method (see Pregnancy and breast-feeding ). Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may impair hormonal contraceptives. Pregnancy has occurred in women taking efavirenz, one of the ingredients in Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, while using a contraceptive implant, although it has not been established that efavirenz treatment was the reason for the lack of a preventive effect.
  • Sertraline, a medicine used to treat depression, your doctor may change your dose of sertraline.
  • Bupropion, a medicine used to treat depression or to help quit smoking, your doctor may change your dose of bupropion.
  • Diltiazem or similar medicines (so-called calcium channel blockers ): When you start taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, your doctor may need to adjust your dose of the calcium channel blocker.
  • Drugs used to prevent rejection of transplanted organs (and also called immunosuppressive drugs)  such as cyclosporine, sirolimus, or tacrolimus. When you start or stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, your doctor will make close checks on your plasma levels of the immunosuppressive drug and may need to adjust its dose.
  • Warfarin or acenocoumarol (medicines used to inhibit blood clotting ): Your doctor may need to adjust your dose of warfarin or acenocoumarol.
  • Extract of Ginkgo biloba (an herbal medicine).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women should not become pregnant during treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Krka or for 12 weeks thereafter. Your doctor may ask you to take a pregnancy test to make sure you are not pregnant before starting your treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Krka.

If you could become pregnant during treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, you must use a reliable barrier contraceptive method (eg condoms) together with other contraceptive methods such as tablets ( pills ) or other hormonal contraceptive methods (eg implants, injection ). Efavirenz, one of the ingredients of Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, may remain in the blood for some time after stopping treatment. Therefore, you should continue to use contraception, as described above, for 12 weeks after stopping Efavirenz / Emtricitabine / Tenofovir disoproxil Krka.

Tell your doctor immediately if you are pregnant or planning to become pregnant. If you are pregnant, you should take Efavirenz / Emtricitabine / Tenofovir disoproxil Krka only if you and your doctor decide that there is a clear need.

Serious malformations have been observed in fetal animals and neonates to women treated with efavirenz during pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

If you have taken Efavirenz / Emtricitabine / Tenofovir disoproxil Krka during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to check your baby’s development. For children whose mothers took NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.

Do not breast-feed during treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Krka. Both HIV and the ingredients in Efavirenz / Emtricitabine / Tenofovir disoproxil Krka can be transferred to breast milk and can seriously harm your baby.

Driving and using machines

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may cause dizziness, impaired concentration, and drowsiness. If you get these symptoms, do not drive, use any tools or machines.

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose ie essentially ‘sodium-free’.

How to use Efavirenz / Emtricitabine / Tenofovir disoproxil Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

One tablet once a day by mouth. Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is recommended for use on an empty stomach (usually defined as 1 hour before or 2 hours after a meal), preferably at bedtime. This may help reduce certain side effects(eg dizziness, drowsiness). Swallow Efavirenz / Emtricitabine / Tenofovir disoproxil Krka whole with water.

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka must be taken daily.

If your doctor decides to stop one of the ingredients in the efavirenz/emtricitabine/tenofovir disoproxil Krka, you can get efavirenz, emtricitabine, and/or tenofovir disoproxil separately or with other medicines to treat your HIV – infection.

If you use more Efavirenz / Emtricitabine / Tenofovir disoproxil Krka then you should 

If you accidentally take too many tablets of efavirenz/emtricitabine/tenofovir disoproxil Krka, you may be at greater risk of any side effect s of this medicine (see section 4, Possible side effect s ). Contact your doctor or nearest emergency department for advice. Save the jar so you can easily describe what you took.

If you forget to use Efavirenz / Emtricitabine / Tenofovir disoproxil Krka

You mustn’t miss any dose of Efavirenz / Emtricitabine / Tenofovir disoproxil Krka.

If you miss a dose of Efavirenz / Emtricitabine / Tenofovir disoproxil Krka within 12 hours of the time it is usually taken, take it as soon as possible, and then take the next dose at its regular time.

If it is almost time (less than 12 hours) for the next dose, do not take the missed dose. Wait and take the next dose at its regular time. Do not take a double dose to make up for a forgotten tablet.

If you vomit the tablet (within 1 hour of taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka), take a new tablet. Do not wait until it is time for your next tablet. You do not need to take a new tablet if you vomit more than 1 hour after taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka.

If you stop using Efavirenz / Emtricitabine / Tenofovir disoproxil Krka

Do not stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka without talking to your doctor. Discontinuation of Efavirenz / Emtricitabine / Tenofovir disoproxil Krka may seriously affect your response to treatment in the future. If you have stopped taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka, talk to your doctor before taking Efavirenz / Emtricitabine / Tenofovir disoproxil Krka again. If you have problems or need to adjust your dose, your doctor may consider giving you the ingredients of Efavirenz / Emtricitabine / Tenofovir disoproxil Krka separately.

When your tablets start to run out, be sure to get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase as soon as you stop taking the medicine, even if it is only for a short time. The virus can then become more difficult to treat.

If you have both HIV – infection and hepatitis B, it is especially important not to stop treatment without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis worsens when treatment is stopped with emtricitabine or tenofovir disoproxil (two of the three ingredients in Efavirenz / Emtricitabine / Tenofovir disoproxil Krka). If treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is stopped, your doctor may recommend that you resume hepatitis B ‑ treatment. You may need to submit blood samples for 4 months after stopping treatment to check your liver function. In some patients with advanced liver disease or cirrhosis, it is not recommended that treatment be discontinued as this may lead to worsening of hepatitis A, which may be fatal.

 Tell your doctor immediately about new or unusual symptoms that occur after stopping treatment, especially symptoms associated with hepatitis B infection.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible serious side effects: contact a doctor immediately

  • Lactic acidosis (excess lactic acid in the blood) is rare (can occur in up to 1 in 1,000 patients) but serious side effects that can be life-threatening. The following side effects may be signs of lactic acidosis:
    • deep, rapid breathing
    • fatigue
    • nausea, vomiting, and abdominal pain

→ If you think you have lactic acidosis, contact your doctor immediately.

Other possible serious side effect s

The following side effects are uncommon (may affect up to 1 in 100 people):

  • allergic reactions (hypersensitivity) that can cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
  • swelling of the face, lips, tongue, or throat
  • angry behavior, suicidal thoughts, strange thoughts, paranoia, inability to think clearly, the influence of mood, see or hear things that do not really exist (hallucinations), suicide attempts, personality changes ( psychosis ), catatonia (the patient ends up in an immobile and dumb state during a period)
  • abdominal pain (stomach) caused by inflammation of the pancreas
  • forgetfulness, confusion, seizures, incoherent speech, tremor (tremors)
  • yellow skin or yellow eyes, itching or pain in the abdomen (stomach) caused by inflammation of the liver
  • damage to the renal tubules.

Mental side effects in addition to the side effects listed above, imagination (false beliefs), neuroses. Some patients have committed suicide. The problems tend to occur more often in those who have previously had a mental illness. Always contact your doctor immediately if you experience these symptoms.

Hepatic side effects: If you also have a hepatitis B virus infection, you may experience a worsening of your hepatitis when treatment is stopped (see section 3).

The following side effects are rare (may affect up to 1 in 1,000 people):

  • liver failure, which in some cases leads to death or liver transplantation. Most cases have occurred in patients who already had liver disease, but there have been a few reports of patients without existing liver disease.
  • kidney inflammation, that you urinate a lot, and that you feel thirsty
  • back pain caused by kidney problems, including kidney failure. Your doctor may take blood samples to check that your kidneys are working properly.
  • Impaired bone hardness (which causes bone pain and sometimes leads to fractures ) can occur due to damage to kidney tubules
  • fatty liver

→ Contact your doctor if you think you may have any of these serious side effects.

The most common side effects are

The following side effects are very common (may affect more than 1 in 10 people):

  • dizziness, headache, diarrhea, nausea, vomiting
  • rash (including red spots or spots sometimes with blistering and swelling of the skin), which may be allergic reactions
  • feeling weak

Samples can also show:

  • lowering of phosphate levels in the blood
  • elevated levels of creatine kinases in the blood that can cause muscle pain and muscle weakness

Other possible side effects are

The following side effects are common (may affect up to 1 in 10 people):

  • allergic reactions
  • coordination and balance disorders
  • worried or depressed
  • difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
  • pain, abdominal pain
  • indigestion which results in discomfort after meals, feeling of bloating, flatulence
  • no appetite
  • fatigue
  • itching
  • discoloration of the skin including dark spots on the skin that often begin on the hands and soles of the feet

Samples can also show:

  • low white blood cell count (a decrease in white blood cell count may make you more likely to get an infection )
  • liver and pancreatic disorders
  • elevated levels of fatty acids ( triglycerides ), bilirubin in the blood, or elevated blood sugar

The following side effects are uncommon (may affect up to 1 in 100 people):

  • muscle breakdown, muscle pain, or muscle weakness
  • anemia (low red blood cell count )
  • the feeling of tingling or dizziness, wheezing, ringing, or another persistent sound in the ears
  • dimsyn
  • frostbite
  • breast augmentation in men
  • reduced sexual drive
  • herds
  • dry mouth
  • increased appetite

Samples can also show:

  • decreased potassium levels in the blood
  • elevated creatinine levels in the blood
  • protein is in the urine
  • elevated blood cholesterol levels

Muscle breakdown decreased bone hardness (which causes bone pain and sometimes leads to fractures ), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood can occur due to damage to kidney tubules.

The following side effects are rare (may affect up to 1 in 1,000 people):

  • the itchy rash caused by a reaction to sunlight

5. How to store Efavirenz / Emtricitabine / Tenofovir disoproxil Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and can after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Close the jar tightly. Moisture sensitive.

Shelf life after opening: 2 months when stored below 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are efavirenz, emtricitabine and tenofovir disoproxil. One film-coated tablet contains 600 mg efavirenz, 200 mg emtricitabine, and 245 mg tenofovir disoproxil (as succinate).
  • Other ingredients are Tablet core: microcrystalline cellulose, hydroxypropyl cellulose, sodium lauryl sulfate, croscarmellose sodium, iron oxide red (E172), magnesium stearate, sodium stearyl fumarate. Film coating: poly (vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172), iron oxide yellow (E172). See section 2 ” Efavirenz / Emtricitabine / Tenofovir disoproxil Krka contains sodium ”.

What the medicine looks like and the contents of the pack

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka film-coated tablets are light orange-pink, oval, biconvex, film-coated tablets with scored edges. Tablet dimension: 20 x 11 mm.

Efavirenz / Emtricitabine / Tenofovir disoproxil Krka is available in jars of 30 film-coated tablets, with a child-resistant safety-sealed closure with integrated desiccant which protects your tablets from moisture.

The following pack sizes are available: 1 can of 30 film-coated tablets or 90 (3 cans of 30) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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